On July 26, 2022 Kelun-Biotech (a holding subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd), a clinical-stage biotech company focused on biologic and small molecule discovery and development, reported that it has entered into a collaboration and exclusive license agreement with MSD (the tradename of Merck & Co., Inc Rahway NJ USA), to develop an investigational antibody drug conjugate (ADC) for the treatment of solid tumors (Press release, Merck & Co, JUL 26, 2022, View Source [SID1234616940]).

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Under the terms of the agreement, Kelun-Biotech has granted MSD global, exclusive rights to develop, manufacture and commercialize an investigational ADC. Kelun-Biotech and MSD will also collaborate on the early clinical development of the investigational ADC. In return, Kelun-Biotech will receive an upfront payment of $35mm and is eligible to receive future development, approval and commercial milestone payments totaling up to $901mm, plus tiered royalties on net sales.

This latest transaction follows MSD’s decision earlier this year to exercise an option for worldwide rights, except for the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan), to SKB-264, an investigational TROP2 targeting ADC. SKB-264 is currently being evaluated in a Phase 3 clinical trial for the treatment of metastatic triple-negative breast cancer and in Phase 2 trials for non-small cell lung cancer and advanced solid tumors. Kelun-Biotech and MSD will collaborate on certain early clinical development plans, including evaluating the potential of SKB-264 as a monotherapy and in combination with KEYTRUDA (pembrolizumab) for advanced solid tumors.

"These collaborations with MSD underscore the sophistication and capabilities of Kelun-Biotech’s ADC platform and the potential of our ADC therapeutics," said Dr. Junyou Ge, Chief Executive Officer of Kelun-Biotech. "Incorporating MSD’s deep and broad global expertise with Kelun-Biotech’s innovation power has the potential to generate great development synergy, significantly accelerating the development and commercialization of the collaboration programs. These collaborations will also strengthen our strategic position in building a global, innovative, fully-integrated biopharmaceutical company."

"The collaboration with Kelun-Biotech strengthens and diversifies MSD’s oncology pipeline as we seek to further the potential of ADCs to provide more treatment options and improve outcomes for people with cancer," commented Dr. Eric H. Rubin, senior vice president, oncology early development, MSD Research Laboratories. "We look forward to advancing this collaboration with the Kelun-Biotech team."

On July 26, 2022 Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, "Sun Pharma" and includes its subsidiaries and/or associate companies) and Cassiopea, a subsidiary of Cosmo Pharmaceuticals N.V. (SIX: COPN, XETRA: C43) ("Cosmo") reported the signing of addendums to the License and Supply Agreements for WINLEVI (clascoterone) cream 1% expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia (Press release, Sun Pharma, JUL 26, 2022, View Source [SID1234616957]). In 2021, Sun Pharma and Cassiopea had signed License and Supply Agreements for the United States and Canada markets. Sun Pharma launched WINLEVI in the US market in November 2021.

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Under the terms of the above referred agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of US$ 7 million, potential regulatory and sales milestones and customary double-digit royalties on net sales.

Aalok Shanghvi, EVP & Head – Generic R&D, Generic Global BD and Emerging Markets, Sun Pharma said, "WINLEVI is a new class of topical medication and it continues to generate significant interest amongst dermatologists in the US. The expansion of our agreement with Cosmo will enable us to make this new acne treatment available to patients in many more countries and is in line with our strategy to build a global portfolio of specialty products."

Diana Harbort, President of Cosmo Dermatology Division, said: "We are very pleased to expand our agreement with Sun Pharma making WINLEVI available to more patients around the world. Sun Pharma’s early success with WINLEVI in the US makes us highly confident of their ability to maximize the opportunity in the expanded territory."

A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. Although its exact mechanism of action is unknown, laboratory studies suggest that WINLEVI works by inhibiting the effects of androgen receptors in cells of the sebaceous glands (oil-producing glands in the skin) to help reduce sebum (oil) production and inflammation.3 It is suitable for use in both males and females.1 WINLEVI is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years.1,2

On July 26, 2022 Sirnaomics Ltd. (the "Company" or "Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that the Company has received regulatory clearance from the Taiwan Ministry of Health and Welfare (TMHW) of its Investigational New Drug (IND) application to commence a Phase I trial of STP705, siRNA (small interfering RNA) drug candidate, for the treatment of patients with advanced liver tumors (Press release, Sirnaomics, JUL 26, 2022, View Source [SID1234616974]).

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The Phase I multicenter, open-Label, dose escalation study in Taiwan is part of a global study of STP705 designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity. STP705 is administered intratumorally for cholangiocarcinoma, hepatocellular carcinoma, or liver metastases in subjects with advanced/metastatic or surgically unresectable solid tumors who are refractory to standard therapy. The study was started in the United States in March 2021, and the study in Taiwan is expected to begin enrolling in the coming months.

"The IND green light in Taiwan for STP705 represents a major milestone for the Company’s expansion of its clinical studies into Asia," said Dr. Patrick Lu, founder, chairman of the Board, Executive Director, President and CEO of Sirnaomics. "We believe that the study results in Taiwan will strengthen the body of data in a multicenter global trial, which will also include a future study in the mainland China. Sirnaomics is currently in a strong position to lead the way in RNAi therapeutics for the development of novel oncology therapies."

"This IND approval will allow more opportunities to manage critical diseases such as liver cancer with high unmet clinical need in Taiwan and the region," stated Steven Long, Ph.D. Sirnaomics Chief Development Officer. "Taiwan’s regulatory bodies and clinical testing hospitals are well known for meeting international standards. We expect to conduct more oncology clinical studies in Asia-Pacific regions in the coming years."

About STP705

STP705 is composed of two siRNA oligonucleotides, targeting TGF-β1 and COX-2 mRNA respectively, formulated in nanoparticles with a Histidine-Lysine Co-Polymer (HKP) peptide as the carrier. Each individual siRNA was demonstrated to inhibit the expression of the target mRNA, and combining the two siRNA’s produces a synergistic effect that diminishes pro-inflammatory factors. Over-expressions of TGF-β1 and COX-2 have been well-characterized in playing key regulatory roles in tumorigenesis.

On July 26, 2022 Diffusion Pharmaceuticals Inc. (NASDAQ: DFFN) ("Diffusion" or the "Company"), a biopharmaceutical company developing novel therapies to enhance the body’s ability to deliver oxygen to areas where it is needed most, reported that after collaboration with the United States Food and Drug Administration ("FDA") on the design of their Phase 2 clinical trial entitled "Open-Label, Dose-Escalation, Phase 2 Safety and Efficacy Study of TSC in Newly Diagnosed Glioblastoma ("GBM") Patients when Administered with Standard of Care ("SOC")" (Press release, Diffusion Pharmaceuticals, JUL 26, 2022, View Source [SID1234617369]). The trial will be designated Study 200-208. The Company expects to initiate the trial by the end of 2022 and anticipates dosing the first patient in the trial in the first quarter of 2023.

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GBM is an aggressive, deadly, and treatment-resistant type of malignant brain tumor, affecting approximately 13,000 newly diagnosed patients each year in the United States. Few treatment options are available for patients with GBM, and none have extended life expectancy beyond a few months. In fact, according to the National Brain Tumor Society, the five-year survival rate for GBM is only 6.8 percent with an average survival time of eight months.

"Effective treatment of GBM remains a significant unmet need and we believe in the potential for TSC to enhance the effectiveness of standard of care therapy for GBM," said Robert Cobuzzi, Jr., Ph.D., President and Chief Executive Officer of Diffusion. "These tumors are known to be hypoxic, which reduces the effectiveness of radio-, chemo-, and immunotherapeutic approaches and promotes tumor cell metastases. We have previously received Orphan Drug designation from the FDA for treatment of GBM with TSC in conjunction with radiotherapy. With the results of the TCOM and Altitude Trials, we now have better data on TSC dosing compared to the previous GBM trials, and we have used these data to design a unique trial that not only will allow us to evaluate the effects of TSC on key clinical outcomes such as survival, but the use of PET imaging also will enable us to obtain data on the direct effects of TSC on GBM tumor oxygenation well before clinical outcome data is typically available in clinical trials involving GBM patients."

The study will include a dose-escalation phase, enrolling patients in a 3+3+3 design, to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TSC at doses of 1.5 mg/kg, 2.0 mg/kg and 2.5 mg/kg administered in combination with concomitant standard of care radiotherapy ("RT") plus temozolomide. An additional 17 subjects will be treated at the highest tolerable dose identified in the dose escalation phase. The primary objective of the study is to evaluate the safety and tolerability of TSC for the treatment of patients with newly diagnosed GBM when administered with SOC. Secondary objectives of the study are to evaluate progression-free survival at six months by magnetic resonance imaging, assessment using Response Assessment in Neuro-Oncology criteria, and to evaluate overall survival at 12 months.

Study 200-208 will vary in a variety of ways from the GBM trials conducted by Diffusion in the past, including three particularly notable differentiators:

The 1.5 mg/kg to 2.5 mg/kg doses of TSC to be administered in the study will be 6-10-fold higher than the 0.25 mg/kg dose used in Diffusion’s prior GBM trials.

TSC will be administered five days each week approximately 30-60 minutes prior to radiotherapy, as compared to the three days per week regimen in Diffusion’s prior GBM trials.

The study trial will incorporate PET scans to directly evaluate the oxygen enhancing effects of TSC on tumor hypoxia using one of two radiotracers, 18F-FMISO or 18F-FAZA, with initial data readouts expected to be available within one year of the study’s initiation.
"For patients with hypoxic tumor microenvironments such as glioblastoma, radiation can be less effective. Diffusion Pharmaceutical’s proposed phase 2 trial of Trans Sodium Crocetinate (TSC) for glioblastoma patients may help to overcome the relative resistance of the hypoxic tumor to ionizing radiation. Improvements in the clinical outcomes for high-grade glioma patients are critically needed," said Dr. Jason Sheehan, MD, PhD, Neurosurgeon at University of Virginia School of Medicine.

"With Glioblastoma Awareness Day on July 20th serving as a stark reminder of the continued unmet need for this disease, our team is incredibly motivated to work with our clinical investigators to get this uniquely designed trial started to explore the potential of TSC to improve outcomes for patients suffering from this devastating diagnosis," noted Chris Galloway, MD, Chief Medical Officer of Diffusion.

On July Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that it has been included in the FTSE4Good Index Series for the 21st consecutive year since its initial inclusion in 2002 (Press release, Eisai, JUL 26, 2022, View Source [SID1234616923]). The FTSE4Good Index Series is a global index series for socially responsible investment.

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The FTSE4Good Index Series was developed by FTSE Russell to promote investment in companies that meet global environmental, social and governance (ESG) standards. Eisai received particularly high scores in "Corporate Governance", "Customer Responsibility", "Labor Standards" and "Tax Transparency", among others. As of the end of June 2022, 1,092 companies worldwide and 224 Japanese companies were included in the FTSE4Good Developed Index Series.

Currently, in addition to the MSCI ESG Leaders Indexes, another global ESG investment index, Eisai is also listed in the FTSE Blossom Japan Index, the FTSE Blossom Japan Sector Relative Index, the MSCI Japan ESG Select Leaders Index, the MSCI Japan Empowering Women Index (WIN) and the S&P/JPX Carbon Efficient Index, which are ESG investment indices for Japanese stocks adopted by the Government Pension Investment Fund (GPIF).

Eisai’s corporate concept is to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides to them, as well as address diverse healthcare needs worldwide. By strengthening its ESG initiatives and increasing non-financial value, Eisai is striving to sustainably enhance corporate value based on this concept.